Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer. More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
Identify and assist in the management of safety concerns with the company’s drug product(s). Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor. Responsible for writing documents required for assessment & communication of product safety information for core safety documents.
Key Accountabilities/Core Job Responsibilities:
- Signal detection activities
- Perform aggregate safety data tabulation and listing compilation
- Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns
- Contribute to development & maintenance of product safety profile
- Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
- Support the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
- Draft regulatory inquiry responses
- Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director
- Perform literature search and review
- Participate in submission activities (ISS, 120-day safety update) as necessary
- Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners
Qualifications and Requirements (degree, certifications, etc. and other requirements):
- MSc, Pharm.D., Ph.D. or M.D.
- Minimum of 5 years experience with pharmacovigilance or clinical safety
- Previous experience in scientific /medical writing is desired
- Ability to read and collate scientific and medical literature
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
- Working knowledge of MedDRA dictionary
- Familiarity with common Safety databases (e.g. Argus, Aris , etc) is preferred
- Proficient with Windows: MS Word, Excel, Power Point and ability to learn new programs as needed
- Must have excellent writing and communication skills
- Collaborate effectively with the study team, cross-functional team members, and external partners.